BEUDAMED
    FDA Enforcement Class II Terminated

    Altius M-INI OCT Posterior Spinal Fixation System, Model Number 1200-9216 The AltiusTM OCT and AltiusTM M-INITM OCT Systems when intended to promote fusion of the cervical spine and occipitocervico-thoracic junction (Occiput-T3), these systems are indicated for: DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); spondylolisthesis; spinal stenosis; fracture/dislocation; atlantoaxial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors. The occipital bone screws are limited to occipital fixation only

    Recall: Z-1691-2017 · Reported April 5, 2017

    Enforcement

    Recall Number
    Z-1691-2017
    Event ID
    76610
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet Spine, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 5, 2017
    Initiation Date
    March 16, 2017
    Classification Date
    March 28, 2017
    Termination Date
    July 30, 2018
    Address
    310 Interlocken Pkwy, Suite 120, Broomfield, CO, 80021-3479, United States

    Description

    Altius M-INI OCT Posterior Spinal Fixation System, Model Number 1200-9216 The AltiusTM OCT and AltiusTM M-INITM OCT Systems when intended to promote fusion of the cervical spine and occipitocervico-thoracic junction (Occiput-T3), these systems are indicated for: DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); spondylolisthesis; spinal stenosis; fracture/dislocation; atlantoaxial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors. The occipital bone screws are limited to occipital fixation only

    Reason

    Zimmer Biomet is recalling the Altius M-INI OCT Posterior Spinal Fixation System because the driver is unable to mate with the screw head tulip.

    Code Info

    505951,M16562R01,505951,510710,510981,514814,533566,536398,543663,546565,546566,549528,565465,565464,567525,

    Distribution

    Worldwide Distribution - US (nationwide) and Internationally to the Netherlands

    Quantity

    141